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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The PIC/S guideline (PIC/S 2004) defines this as a 'computer related system'. [10] Much effort is expended within the industry upon validation activities, and several journals are dedicated to both the process and methodology around validation, and the science behind it. [11] [12] [13] [14]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Pharmaceutical companies, market research agencies, and other organizations involved in the pharmaceutical industry are all included in the membership of EPHMRA. Today, the organization continues to have a significant impact on the future of pharmaceutical market research in Europe, providing a platform for industry professionals to discuss ...
1977: The FDA creates a guideline to exclude women of reproductive potential from participating in early phase clinical research, except for life-threatening conditions. This is broadly applied ...
3. Bojangles. Bojangles is a game of highs and lows. I hate some things (read: fries) and adore others (read: sweet potato pie) and the new nuggets, or, “Bo Bites” as they are called, really ...
Template:Pharmaceutical Affordability and Access; Pharmaceutical Benefits Scheme; Pharmaceutical distribution; Pharmaceutical fraud; Pharmaceutical industry in China; Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme; Pharmaceutical Press; Pharmaceutical Price Regulation Scheme; Pharmacovigilance